Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 4, April 2012
A new page has been added to the HS-IRBs website specifically for new investigators. Information for New Investigators includes general step-by-step guidance regarding the IRB review process and links to a variety of resources. In addition to the resources available on the website, new investigators are strongly encouraged to schedule a consultation before submitting their first application to the HS or MR-IRB. To schedule a consultation, please fill out the request form available here: https://ictr.wisc.edu/irb.
Timelines for study teams to respond to issues raised by the IRB has now been standardized. Study teams have 90 days to respond to pre-review, modifications requested after an IRB meeting, and IRB deferral requests. Study teams will receive email reminders to submit a response at 30 and 60 days after issues have been sent to the study team.
After 90 days with no response from the study team, submissions will automatically transition to the IRB Withdrawn state. Study teams then have 12 months to request reactivation before the submission is automatically archived. Study teams who repeatedly time out and request reactivation may be asked to submit a new application.
The Record Human Subjects Training Snapshot activity is now live in ARROW. This means study teams can check the training certifications for all key personnel listed on a specific study. Study teams should use this activity before submitting new applications or personnel changes. For instructions on how to use this new activity, please see [Link for document 23550 is unavailable at this time.]. Please also keep the following in mind:
Study teams are reminded of the need to review all correspondence from the HS-IRBs, including approval letters. Correspondence can include additional requirements that must be met by the study team. Study teams who do not meet the requirements included in IRB correspondence may need to submit a report of potential noncompliance. Study teams who have questions about letters they receive from the IRB should contact the IRB staff reviewer assigned to that submission for additional guidance.
Study teams often ask how they should handle multiple submissions (e.g., change of protocol + continuing review + reportable event) for the same study. Please see I have a change of protocol and a continuing review coming up. Which should I submit first? for some tips on what to submit when if multiple submissions are pending for the same study. Study teams also are encouraged to call the HS-IRBs Office for advice.
After a submission is scheduled for an IRB meeting, the history tab is currently not displaying the specific IRB meeting date. The meeting date is displayed in the top portion of the submission workspace for all initial review applications. For a continuing review, full change of protocol, or reportable event, study teams can contact the staff reviewer assigned to that submission to find out to what meeting it has been assigned. In general, however, full continuing reviews and full changes of protocol are assigned to meetings about 2 weeks in advance of the meeting date; some continuing reviews may be assigned up to a month in advance. Reportable events that require review by the full IRB may be scheduled 1-2 weeks in advance of the meeting date. In the near future, ARROW will be updated to display the meeting date in the submission workspace for all submissions.